# K021317: Triage B-Type Natriuretic Peptide (BNP) Test

- Pathway: 510(k) (Traditional)
- Applicant: Biosite Incorporated
- Decided: Jul 1, 2002 after 67 days
- Product code: NBC (Test, Natriuretic Peptide)
- Device class: 2
- Regulation: 21 CFR 862.1117
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
13 later devices descend from it; 6 cite it directly.
3 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Triage BNP Test: named in the summary without a submission number
- (no number) Dade Stratus Cardiac Troponin-I: named in the summary without a submission number
- (no number) Dade Dimension RxL Cardiac Troponin4: named in the summary without a submission number

## Most influential descendants
- K051787: Triage BNP Test, Model 98000XR (2005), 6 descendants of its own
- K052789: Triage BNP Test for Beckman Coulter Immunoassay Systems, Model 98200 (2006), 4 descendants of its own
- K080269: Triage Cardioprofiler and Profiler S.O.B. Panels (2008), 3 descendants of its own
- K030286: Triage Cardio Profiler/Triage Cardiac Panel (2003), 3 descendants of its own
- K093758: BGM Galectin -3 (2010), 2 descendants of its own

## Indications for use
The Triage BNP Test is intended for use with the Triage Meter for the rapid in vitro quantitative measurement of B-Type Natriuretic Peptide (BNP) in human whole blood or plasma specimens using EDTA as the anticoagulant. The test is used as an aid in the diagnosis and assessment of severity of congestive heart failure. The test also is used for the risk stratification of patients with acute coronary syndromes.

Source page: https://510kreport.com/device/K021317
Methodology: https://510kreport.com/methodology